QA Specialist II

Employer
Bachem
Location
Vista, CA, US
Posted
Oct 26, 2020
Ref
592255801
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time
Your Responsibilities

The Quality Assurance Specialist II fulfills a critical role for Quality Assurance. This individual will conduct real time batch record review, perform internal audits, contribute to GMP system improvements, write technical documents, and review GMP documentation and reports. This individual must also provide GMP and related training.

Your Tasks

Review validation protocols, data and reports, as assigned

Coordinate assigned quality systems, such as GMP training program, deviations, CAPAs, or change controls

Perform annual product quality reviews and system reviews as assigned

Review raw material records

Provide support to customer and regulatory audits.

Conduct internal audits as assigned

Implement improvements in quality systems and SOPs

Review and update assigned documents, such as SOPs, including line clearances, and shipment verification, equipment qualification and documentation control

Provide technical assistance on all production & quality systems documents

Organize and update document room files as required

Assist with ad hoc QA projects and other duties as assigned

Your Profile

A Bachelor's Degree in Science or related field - Chemistry degree preferred and a minimum of 3 years' experience in the GMP / Manufacturing setting or

Associates Degree in Science or related field and Chemistry preferred and a minimum of 5 years' experience in the GMP / Manufacturing setting

3 years' work experience in GMP manufacturing

Experience in GMP manufacturing, Quality Assurance and/or Quality Control

Experience with GMP document control, validation, qualification and calibration

Ability to work in ISO7 and ISO8 control environment and support real time batch record review

Experience in internal auditing as well as working with regulatory agencies

Excellent written and oral communication skills

Basic computer knowledge, including Microsoft Word, Excel and PowerPoint

Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment

Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues.

Detail oriented with the ability to troubleshoot and resolve problems

Ability to work independently and manage one's time

Communicate effectively and ability to function well in a team environment

We Offer

You will be part of a motivated team overseeing the entire development cycle of respective APIs. If you are looking for a new challenge and want to join a motivated team in an internationally renowned company, you should seize this opportunity.

Nearest Major Market: San Diego